Cleared Special

K253664 - SKOUT system (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253664 · Iterative Health · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
32d
Days
Class 2
Risk

K253664 is an FDA 510(k) clearance for the SKOUT system. Classified as Gastrointesinal Lesion Software Detection System (product code QNP), Class II - Special Controls.

Submitted by Iterative Health (Cambridge, US). The FDA issued a Cleared decision on December 22, 2025 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1520 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Iterative Health devices

Submission Details

510(k) Number K253664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2025
Decision Date December 22, 2025
Days to Decision 32 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QNP Gastrointesinal Lesion Software Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1520
Definition A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QNP Gastrointesinal Lesion Software Detection System

All 18
Devices cleared under the same product code (QNP) and FDA review panel - the closest regulatory comparables to K253664.
MAGENTIQ-COLO (ME-APDS)
K260724 · Magentiq Eye, Ltd. · Apr 2026
MAGENTIQ-COLO (ME-APDS)
K252178 · Magentiq Eye, Ltd. · Oct 2025
CADDIE
K252586 · Odin Medical Limited · Sep 2025
SKOUT system
K251126 · Iterative Health · May 2025
MAGENTIQ-COLO (ME-APDS)
K244023 · Magentiq Eye, Ltd. · Jan 2025
GI Genius™ Module 100 (GGM100.US)
K241887 · Cosmo Artificial Intelligence - Ai, Ltd. · Jul 2024